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Evaluating azetukalner for treating major depressive disorder

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder

Phase 3 Interventional Xenon Pharmaceuticals Inc. · NCT06775379

This study is testing a new medication called azetukalner to see if it can help adults with major depressive disorder feel better compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment450 (estimated)
Ages18 Years to 74 Years
SexAll
SponsorXenon Pharmaceuticals Inc. Industry-sponsored
Locations46 sites (Phoenix, Arizona and 45 other locations)
Trial IDNCT06775379 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial is a multicenter, randomized, double-blind, placebo-controlled study designed to assess the efficacy, safety, and tolerability of azetukalner as a monotherapy in adults diagnosed with Major Depressive Disorder (MDD). Participants will be randomly assigned to receive either azetukalner or a placebo, and their responses will be monitored over the course of the study. The trial aims to provide robust data on the potential benefits of azetukalner in alleviating symptoms of depression.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 74 who are experiencing their first major depressive episode and meet specific diagnostic criteria.

Not a fit: Patients with other mood disorders or specific exclusions such as bipolar disorder or schizophrenia may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients suffering from major depressive disorder.

How similar studies have performed: Previous studies evaluating similar antidepressant approaches have shown promise, but the specific efficacy of azetukalner is being tested for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Adults ≥18 and ≤74 years of age and experienced their first major depressive episode (MDE) prior to 50 years of age
* Body Mass Index (BMI) ≤40 kg/m2
* Meets the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) criteria for current major depressive disorder and is currently in an MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI)
* Participant's current MDE has a duration of ≥6 weeks and ≤24 months.

Key Exclusion Criteria:

* Participant has a primary diagnosis of a mood disorder other than MDD.
* Participant has a history of any of the following: MDD with psychotic or catatonic features; MDD with mixed features; Bipolar I or II disorder; Obsessive-compulsive disorder; Schizophrenia, primary thought disorder, or other psychotic disorder.
* Participant has a current diagnosis of any of the following: MDD with seasonal pattern; Depression with peripartum or perimenopausal onset; Post traumatic stress disorder; Antisocial or borderline personality disorder (or presence of clinically significant borderline personality traits); Panic disorder and/or agoraphobia; ADHD treated with a psychostimulant, diagnosed during the current MDE, or with unstable symptoms, as judged by the investigator.
* Participant has a substance (excluding tobacco) or alcohol use disorder within the 12 months prior to screening.
* Participant has had an active suicidal plan/intent within the 6 months prior to screening, presence of suicidal behavior in the last 2 years, or \>1 suicide attempt \>24 years of age.
* Participant has a history of non-suicidal self-harm behavior in the 12 months prior to screening.
* Participant has used antidepressants or other prohibited medications (including benzodiazepines), within the 2 weeks (4 weeks for fluoxetine) or within a period less than 5 times the drug's half-life, whichever is longer, prior to randomization.
* Participant has a history of non-response to ≥2 antidepressant drugs of adequate dose and duration in the current MDE as determined by the Antidepressant Treatment Response Questionnaire (ATRQ).
* Participants with medical conditions that may interfere with the purpose or conduct of the study
* Participant is pregnant, breastfeeding, or planning to become pregnant.

Where this trial is running

Phoenix, Arizona and 45 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Major Depressive DisorderDepressionAntidepressantXEN1101Azetukalner
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.